Belinostat (PXD101) has been evaluated across numerous clinical trials ranging from Phase 1 to Phase 3, investigating hematologic malignancies and solid tumors, including peripheral T-cell lymphoma, acute myeloid leukemia, myelodysplastic syndromes, neuroendocrine tumors, and metastatic breast cancer. Sponsored by academic medical centers, government organizations such as the National Cancer Institute, and pharmaceutical companies like Acrotech Biopharma and Pfizer, trial recruitment statuses include completed, active, and recruiting cohorts. These studies evaluate combination therapies, targeted regimens, and genotype-directed dosing strategies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06072131 | RECRUITING | Peripheral T Cell Lymphoma |
Acrotech Biopharma Inc. |
2023-10-04 | PHASE3 |
| NCT07691450 | NOT_YET_RECRUITING | Recurrent Anaplastic Large Cell Lymphoma; Recurrent Enteropathy-Associated T-Cell Lymphoma; Recurrent Follicular Helper T-Cell Lymphoma; Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type; Recurrent Follicular Helper T-Cell Lymphoma, Follicular-Type; Recurrent Follicular Helper T-Cell Lymphoma, Not Otherwise Specified; Recurrent Hepatosplenic T-Cell Lymphoma; Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Recurrent Monomorphic Epitheliotropic Intestinal T-cell Lymphoma; Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified; Recurrent Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma; Recurrent Primary Cutaneous Gamma-Delta T-Cell Lymphoma; Recurrent Subcutaneous Panniculitis-Like T-Cell Lymphoma; Refractory Anaplastic Large Cell Lymphoma; Refractory Enteropathy-Associated T-Cell Lymphoma; Refractory Follicular Helper T-Cell Lymphoma; Refractory Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type; Refractory Follicular Helper T-Cell Lymphoma, Follicular-Type; Refractory Follicular Helper T-Cell Lymphoma, Not Otherwise Specified; Refractory Hepatosplenic T-Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Monomorphic Epitheliotropic Intestinal T-cell Lymphoma; Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified; Refractory Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma; Refractory Primary Cutaneous Gamma-Delta T-Cell Lymphoma; Refractory Subcutaneous Panniculitis-Like T-Cell Lymphoma |
City of Hope Medical Center |
2027-01-03 | PHASE1 |
| NCT04747236 | RECRUITING | PTCL |
University of Virginia |
2021-02-19 | PHASE2 |
| NCT06561048 | RECRUITING | Peripheral T-Cell Lymphoma, Not Otherwise Specified; Angioimmunoblastic T-cell Lymphoma; Follicular T-Cell Lymphoma; Nodal Peripheral T-Cell Lymphoma With TFH Phenotype; Systemic Anaplastic Large Cell Lymphoma; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell |
Corvus Pharmaceuticals, Inc. |
2024-10-02 | PHASE3 |
| NCT06406465 | RECRUITING | Carcinoma, Neuroendocrine; Tumor, Neuroendocrine; Tumors, Neuroendocrine; Neuroendocrine; Carcinoma; Small Cell; Receptors |
National Cancer Institute (NCI) |
2026-09-09 | PHASE2 |
| NCT05627245 | ACTIVE_NOT_RECRUITING | Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Recurrent Follicular Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Recurrent T-Cell Non-Hodgkin Lymphoma; Recurrent Transformed Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Refractory Follicular Lymphoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory T-Cell Non-Hodgkin Lymphoma; Refractory Transformed Non-Hodgkin Lymphoma |
National Cancer Institute (NCI) |
2023-03-01 | PHASE1 |
| NCT05154994 | ACTIVE_NOT_RECRUITING | Infiltrating Urothelial Carcinoma, Sarcomatoid Variant; Locally Advanced Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Unresectable Urothelial Carcinoma |
University of Utah |
2022-01-14 | PHASE1 |
| NCT05170334 | ACTIVE_NOT_RECRUITING | Metastatic Uveal Melanoma |
H. Lee Moffitt Cancer Center and Research Institute |
2021-12-15 | PHASE2 |
| NCT02737046 | COMPLETED | Adult T-cell Leukemia-Lymphoma; ATLL |
University of Miami |
2016-12-12 | PHASE2 |
| NCT04703920 | COMPLETED | Metastatic Breast Cancer; Metastatic Castration-resistant Prostate Cancer; Metastatic Ovarian Carcinoma; Metastic or Unresectable Pancreatic Adenocarcinoma |
University of Michigan Rogel Cancer Center |
2021-03-04 | PHASE1 |
| NCT06406465 | Not yet recruiting | Carcinoma Neuroendocrine|Tumor Neuroendocrine|Tumors Neuroendocrine|Neuroendocrine; Carcinoma|Small Cell; Receptors |
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) |
2024-05-15 | Phase 2 |
| NCT04315233 | TERMINATED | Metastatic Breast Cancer; Recurrent Ovarian Carcinoma |
University of Utah |
2021-05-03 | PHASE1 |
| NCT04340843 | ACTIVE_NOT_RECRUITING | Locally Advanced Unresectable Primary Central Chondrosarcoma; Metastatic Primary Central Chondrosarcoma; Unresectable Primary Central Chondrosarcoma |
National Cancer Institute (NCI) |
2020-09-08 | PHASE2 |
| NCT04315155 | WITHDRAWN | Metastatic Adenocarcinoma |
University of Utah |
2020-10 | PHASE1 |
| NCT02137759 | UNKNOWN | Glioblastoma Multiforme of Brain |
Emory University |
2014-05-07 | PHASE2 |
| NCT04184869 | COMPLETED | Solid Tumor; Hematological Malignancies |
Acrotech Biopharma Inc. |
2019-08-05 | PHASE1 |
| NCT03772925 | TERMINATED | Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Myelodysplastic Syndrome |
National Cancer Institute (NCI) |
2019-06-20 | PHASE1 |
| NCT03432741 | TERMINATED | Breast Adenocarcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma; Recurrent Hodgkin Lymphoma; Recurrent Mycosis Fungoides; Recurrent Non-Hodgkin Lymphoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory Breast Carcinoma; Refractory Hodgkin Lymphoma; Refractory Mycosis Fungoides; Refractory Nodal Marginal Zone Lymphoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Stage IV Breast Cancer AJCC v6 and v7 |
Mayo Clinic |
2018-03-27 | PHASE1 |
| NCT04315233 | Recruiting | Metastatic Breast Cancer|Recurrent Ovarian Carcinoma |
University of Utah|Novartis|Acrotech Biopharma |
2021-05-03 | Phase 1 |
| NCT04703920 | Recruiting | Metastatic Breast Cancer|Metastatic Castration-resistant Prostate Cancer|Metastatic Ovarian Carcinoma |
University of Michigan Rogel Cancer Center|Pfizer|Acrotech Biopharma Inc. |
2021-03-04 | Phase 1 |
| NCT02680795 | COMPLETED | Solid Tumors; Hematological Malignancies |
Acrotech Biopharma Inc. |
2016-04-27 | PHASE1 |
| NCT02532192 | WITHDRAWN | Lymphoma |
M.D. Anderson Cancer Center |
2015-12 | PHASE1 |
| NCT03772925 | Active not recruiting | Recurrent Acute Myeloid Leukemia|Recurrent Myelodysplastic Syndrome|Refractory Acute Myeloid Leukemia|Refractory Myelodysplastic Syndrome |
National Cancer Institute (NCI) |
2019-06-20 | Phase 1 |
| NCT02701673 | WITHDRAWN | Lymphoma |
M.D. Anderson Cancer Center |
2016-06 | PHASE1; PHASE2 |
| NCT02381548 | TERMINATED | Acute Myeloid Leukemia; Acute Myeloid Leukemia Post Cytotoxic Therapy; Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive; Refractory Acute Myeloid Leukemia; Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive; Secondary Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2015-08-18 | PHASE1 |
| NCT00334789 | COMPLETED | Adult Solid Neoplasm |
National Cancer Institute (NCI) |
2006-06-12 | PHASE1 |
| NCT02875002 | WITHDRAWN | Relapsed and Refractory Aggressive B- and T-cell Lymphomas; Lymphoma |
Yale University |
2016-10 | PHASE1 |
| NCT01273155 | COMPLETED | Neoplasms; Lymphomas |
National Cancer Institute (NCI) |
2011-01-10 | PHASE1 |
| NCT00926640 | COMPLETED | Carcinoma Neuroendocrine; Small Cell Lung Carcinoma; Malignant Epithelial Neoplasms |
National Cancer Institute (NCI) |
2009-07-01 | PHASE1 |
| NCT02679131 | TERMINATED | Relapsed/Refractory Solid Tumors/Hematological Malignancies |
Acrotech Biopharma Inc. |
2016-03 | PHASE1 |
| NCT02142530 | COMPLETED | Non-Hodgkin Lymphoma; Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma; Follicular Lymphoma; Peripheral T-cell Lymphoma |
Massachusetts General Hospital |
2014-10 | PHASE1 |
| NCT01686165 | COMPLETED | Anaplastic Large Cell Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Mantle Cell Lymphoma |
University of Arizona |
2012-08-31 | PHASE2 |
| NCT01839097 | COMPLETED | Peripheral T-cell Lymphoma |
Acrotech Biopharma Inc. |
2013-05 | PHASE1 |
| NCT01100944 | TERMINATED | Thymoma; Thymic Carcinoma |
National Cancer Institute (NCI) |
2010-03-04 | PHASE1; PHASE2 |
| NCT01310244 | COMPLETED | Stage IV Non-small Cell Lung Cancer |
Acrotech Biopharma Inc. |
2010-12 | PHASE1; PHASE2 |
| NCT01317927 | COMPLETED | Solid Tumor; Hematological Malignancy |
Spectrum Pharmaceuticals, Inc |
2010-12 | PHASE1 |
| NCT01583777 | COMPLETED | Advanced Cancer |
Acrotech Biopharma Inc. |
2013-09 | PHASE1 |
| NCT01075425 | COMPLETED | Acute Lymphocytic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia |
Virginia Commonwealth University |
2010-05 | PHASE1 |
| NCT00865969 | COMPLETED | Peripheral T-cell Lymphoma |
Spectrum Pharmaceuticals, Inc |
2008-12-15 | PHASE2 |
| NCT00589290 | COMPLETED | Thymoma; Thymic Carcinoma |
National Cancer Institute (NCI) |
2007-12 | PHASE2 |
| NCT00351975 | COMPLETED | Accelerated Phase of Disease; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blastic Phase; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndrome; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia; Previously Treated Myelodysplastic Syndrome; Primary Myelofibrosis; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Disease; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndrome |
National Cancer Institute (NCI) |
2006-06 | PHASE1 |
| NCT00873119 | COMPLETED | Carcinoma of Unknown Primary |
Valerio Therapeutics |
2009-02 | PHASE2 |
| NCT00993616 | COMPLETED | Brenner Tumor; Fallopian Tube Cancer; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer |
National Cancer Institute (NCI) |
2009-12 | PHASE2 |
| NCT01090830 | TERMINATED | Non-Small-Cell Lung Carcinoma |
Holy Cross Hospital, Florida |
2010-04 | PHASE1; PHASE2 |
| NCT00413075 | COMPLETED | Solid Tumor; Lymphoma |
Valerio Therapeutics |
2006-06 | PHASE1 |
| NCT01188707 | TERMINATED | Non Small Cell Lung Cancer |
Herlev Hospital |
2010-10-01 | PHASE1; PHASE2 |
| NCT00357162 | COMPLETED | de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes |
National Cancer Institute (NCI) |
2006-05 | PHASE2 |
| NCT00321594 | COMPLETED | Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer |
National Cancer Institute (NCI) |
2006-05 | PHASE1; PHASE2 |
| NCT00303953 | COMPLETED | Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma |
National Cancer Institute (NCI) |
2006-01 | PHASE2 |
| NCT00348985 | COMPLETED | Adult Grade III Lymphomatoid Granulomatosis; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Primary Central Nervous System Hodgkin Lymphoma; Primary Central Nervous System Non-Hodgkin Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2006-03 | PHASE1 |
| NCT00301756 | COMPLETED | Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma; Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor; Recurrent Ovarian Carcinoma; Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor; Stage III Ovarian Cancer; Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor; Stage IV Ovarian Cancer |
National Cancer Institute (NCI) |
2006-09 | PHASE2 |
| NCT00274651 | TERMINATED | Cutaneous T-Cell Lymphoma; Peripheral T-Cell Lymphoma; Non-Hodgkin's Lymphoma |
Valerio Therapeutics |
2006-01 | PHASE2 |
| NCT00357032 | COMPLETED | Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2006-05 | PHASE2 |
| NCT00365053 | COMPLETED | Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma |
National Cancer Institute (NCI) |
2006-06 | PHASE2 |
| NCT00421889 | COMPLETED | Ovarian Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Bladder Cancer |
Valerio Therapeutics |
2005-08 | PHASE1; PHASE2 |
| NCT00413322 | COMPLETED | Tumor |
Valerio Therapeutics |
2005-09 | PHASE1 |
| NCT00354185 | TERMINATED | Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2006-05 | PHASE1 |
| NCT00431340 | TERMINATED | Multiple Myeloma |
Valerio Therapeutics |
2007-03 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-22)
Check the
Belinostat (PXD101)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Belinostat (PXD101) Mechanism of Action: HDAC Inhibition in T-Cell Lymphocyte Research
- Belinostat (PXD101) Working Concentration | Cell Culture | Treatment
- Belinostat (PXD101) Solubility in DMSO
- Belinostat (PXD101) Stock Solution
- Belinostat (PXD101) Storage
- Belinostat (PXD101) Stability
- Belinostat (PXD101) Combination Database
- Belinostat (PXD101) Molecular Weight
- Belinostat (PXD101) SMILES
- Belinostat (PXD101) CAS Number
- Belinostat (PXD101) Chemical Structure (2D and 3D)
- Belinostat (PXD101) IC50 for Cell-based and Cell-free Assays
- Belinostat (PXD101) Sigma (SML3010)? Try a better option.
- Belinostat (PXD101) MedChemExpress (HY-10225)? Try a better option.
- Belinostat (PXD101) APExBIO (A4612)? Try a better option.
- Belinostat (PXD101) Cayman (34084)? Try a better option.
- Belinostat (PXD101) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.